Actemra Cuts Steroid Needs Even in Nonresponders

Drug may still benefit patients in one respect when disease symptoms persist.

Tocilizumab (Actemra) may have positive effects in patients not showing clinical responses by allowing reductions in corticosteroids doses, according to a five-center French study appearing online in Rheumatology.

Led by rheumatologist Clémentine Fortunet, MD, Dijon University Hospital, Dijon, France, the study found that corticosteroid doses could be significantly reduced after patients started on tocilizumab, with a trend toward greater reductions in patients not meeting criteria for a clinical response to the biologic drug.

The open, observational, retrospective study evaluated 130 patients with rheumatoid arthritis (80.8% female, mean age 56.7 years) from an initial cohort of 220 given oral corticosteroids for more than 3 months. Patients were started on tocilizumab from December 2009 to June 2011.

Over a mean follow-up period of 21.3 weeks during tocilizumab treatment, the mean daily dose of corticosteroids decreased from 10.0 mg at baseline to 8.7 mg at week four, 8.0 mg at week eight, 7.5 mg at week 12, and 6.5 mg at week 24 (P<0.0001). Mean disease activity scores decreased from 5.1 to 3.0 at week 24 (P<0.0001).

A total of 19 patients stopped treatment owing, variously, to side effects, treatment failure, pregnancy or surgery.

By week 24, 53.8% were receiving daily corticosteroid doses of 5 mg or less. Corticosteroids were withdrawn completely in one patient at week four, three patients at week eight, eight patients at week 12, and 15 patients at week 24.

The only variable associated with decreased corticosteroid dose was a higher initial dose (r=0.82, P<0.001), an effect that may be due simply to the greater potential for reduction with higher doses. And it is possible that in patients treated with high-dose corticosteroids, the clinician's main objective is to reduce dosage rather than RA activity, the authors noted.

There was no correlation between week 0-24 changes in daily corticosteroids and changes in the DAS28 (r=-0.1, P=0.2).

At week 24, there was a nonsignificant trend toward a greater reduction in corticosteroids dose in nonresponders to tocilizumab treatment than responders, with a mean decrease of 6.9 mg/day in nonresponders, 1.9 mg/day in moderate responders, and 3.2 mg/day in good responders (P=0.17). With initial corticosteroids doses higher in nonresponders, the authors suggested that patients on high initial doses likely had more severe disease that was less amenable to treatment.

Given the significant corticosteroids sparing during the first months of treatment, even in nonresponders, the authors proposed that tocilizumab could have an important benefit despite the absence of clinical response as conventionally judged.

Addressing limitations, they noted the open observational design and the absence of a comparator, both inherent to real-life studies. Other limitations were the retrospective collection of data, even with the use of standardized case report forms, and the limited follow-up time. "It would be useful to continue to collect data to evaluate whether the results observed are confirmed," the investigators wrote.

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.